FDA.reportPublic FDA data

Ampicillin

Product NDC
0781-2145
11-digit product format
007812145
Labeler code
0781
Product ID
0781-2145_0202d39a-7586-4abd-9b9f-ac935aadccf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA064082
Marketing category
ANDA
Marketing start
1995-08-29
Substance
AMPICILLIN TRIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN TRIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHXQ6A1N7R6
Rxcui308212, 313800

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-2145-012025-07-30C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2145-052025-07-30C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2145-012020-07-20C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2145-052020-07-20C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2145-012020-01-31C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2145-052020-01-31C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2145-01Ampicillin100 in 1 BOTTLECAPSULE10018
0781-2145-05Ampicillin500 in 1 BOTTLECAPSULE50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2145-01EA - Each0781-214522665f6a-b078-4142-ab17-ea1b893b444612012-07-24
0781-2145-05EA - Each0781-214579b4768e-e23e-409e-90fb-3162cb5d0c0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN TRIHYDRATEACTIVE INGREDIENTHXQ6A1N7R6AMPICILLIN CAPSULE [SANDOZ INC]12
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN CAPSULE [SANDOZ INC]12
AMMONIAINACTIVE INGREDIENT5138Q19F1XAMPICILLIN CAPSULE [SANDOZ INC]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMPICILLIN CAPSULE [SANDOZ INC]12
GELATININACTIVE INGREDIENT2G86QN327LAMPICILLIN CAPSULE [SANDOZ INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMPICILLIN CAPSULE [SANDOZ INC]12
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMPICILLIN CAPSULE [SANDOZ INC]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMPICILLIN CAPSULE [SANDOZ INC]12
SHELLACINACTIVE INGREDIENT46N107B71OAMPICILLIN CAPSULE [SANDOZ INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMPICILLIN CAPSULE [SANDOZ INC]12
AMPICILLIN TRIHYDRATEACTIVE INGREDIENTHXQ6A1N7R6AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MAMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XAMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OAMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2145AMPICILLIN CAPSULE [SANDOZ INC]17Current NDC, Legacy NDC, 2 package rows20240514_0a66c5c3-63bf-46e3-835e-26b555ab6954.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313800ampicillin 250 MG Oral CapsulePSN0a66c5c3-63bf-46e3-835e-26b555ab695418
308212ampicillin 500 MG Oral CapsulePSN0a66c5c3-63bf-46e3-835e-26b555ab695418
313800ampicillin 250 MG Oral CapsuleSCD0a66c5c3-63bf-46e3-835e-26b555ab695418
308212ampicillin 500 MG Oral CapsuleSCD0a66c5c3-63bf-46e3-835e-26b555ab695418
308212ampicillin 500 MG Oral CapsulePSN4134cd79-c895-4e6e-b1d5-8e01c38bf2d113
308212ampicillin 500 MG Oral CapsuleSCD4134cd79-c895-4e6e-b1d5-8e01c38bf2d113
308212ampicillin 500 MG Oral CapsulePSN643d9208-f086-15da-e053-2a91aa0ac1003
308212ampicillin 500 MG Oral CapsulePSN90b8409e-2460-0cb7-e053-2995a90a31103
308212ampicillin 500 MG Oral CapsuleSCD643d9208-f086-15da-e053-2a91aa0ac1003
308212ampicillin 500 MG Oral CapsuleSCD90b8409e-2460-0cb7-e053-2995a90a31103
308212ampicillin 500 MG Oral CapsulePSN3b49ec7f-e511-4d98-857b-94a0060277921
308212ampicillin 500 MG Oral CapsuleSCD3b49ec7f-e511-4d98-857b-94a0060277921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2145-0100781214501100 CAPSULE in 1 BOTTLE (0781-2145-01) 100 capsule1995-08-290000-00-00NoNoCurrent
0781-2145-0500781214505500 CAPSULE in 1 BOTTLE (0781-2145-05) 500 capsule1995-08-290000-00-00NoNoCurrent